Adults 18 to 75, any sex, with Nasopharyngeal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR) Assess by Independent Review Committee (IRC)Primary· Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death ，whichever was earlier, approximately 3 years.
Percentage of participants achieved partial response (PR) or complete response (CR) based on IRC assessment according to the RECIST (version 1.1) is presented for this endpoint.
Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks (28 days) after the criteria for response are first met. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response .
Group
Value
95% CI
SHR-1210 Injection
28.3
21.3 – 36.2
ORR Assess by InvestigatorsSecondary· Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.
Percentage of participants achieved partial response (PR) or complete response (CR) based on investigator assessment according to the RECIST (version 1.1) is presented for this endpoint.
Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks (28 days) after the criteria for response are first met. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response.
Group
Value
95% CI
SHR-1210 Injection
24.3
17.8 – 32.0
Duration of Response (DoR)Secondary· Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.
DoR is defined, for participants with a CR or PR per RECIST version 1.1, as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or death, whichever occurs first.
Group
Value
95% CI
SHR-1210 Injection
20.3
13.0 – 30.5
Disease Control Rate (DCR)Secondary· Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.
Percentage of participants achieving PR, CR or SD (SD ≥ 8 weeks) based on IRC assessment according to the RECIST version 1.1 is presented in this endpoint. DCR is a best overall response from the time of first dose to the documented objective progression or the subsequent anti-tumor therapy (whichever occurs first).
Group
Value
95% CI
SHR-1210 Injection
54.6
46.3 – 62.7
Progression-Free Survival (PFS)Secondary· Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.
PFS is defined as the time from the first dose to the date of the first documentation of PD or death, whichever occurs first. PFS was based on investigator assessment according to the RECIST version 1.1. PFS time was summarized using the Kaplan-Meier method.
Group
Value
95% CI
SHR-1210 Injection
3.7
2.0 – 5.4
Overall Survival (OS)Secondary· Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.
Overall Survival is defined as the time from the first dose to death due to any cause. OS time was measured using the Kaplan-Meier method.
Group
Value
95% CI
SHR-1210 Injection
18.7
15.2 – 20.1
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs should be reported from the time the participant has taken at least 1 dose of study treatment through the participant's last visit (approximately 3 years)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is an open label, single-arm, multi-center, phase 2 Study of SHR-1210 in recurrent/metastatic nasopharyngeal carcinoma(R/M NPC) patients who have received previous at least two lines of chemotherapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05799183 — A SHR-1210 BE Study on Healthy Subjects
· Phase 1
· terminated
NCT04533490 — A Phase Ⅱ Clinical Trial of Camrelizumab for Adjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma
· Phase 2
· unknown
NCT04680988 — A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer
· Phase 2
· completed
NCT04790539 — a Study of SHR1210 in Combination With Paclitaxel-albumin and Carboplatin in Extensive Stage Small Cell Lung Cancer
· Phase 2
· unknown
NCT04506242 — Camrelizumab With Apatinib as Neoadjuvant Therapy for Participants With Resectable Non-Small Cell Lung Cancer
· Phase 2
· unknown
Other recruiting trials for Nasopharyngeal Carcinoma
Currently open trials in the same condition.
NCT06059261 — Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC.
· Phase 2
· recruiting
NCT07328854 — 40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma
· Phase 3
· recruiting
NCT06912711 — TN Induction and Adjuvant Therapy for Resectable Local Recurrent Nasopharyngeal Carcinoma
· Phase 2
· recruiting
NCT07000643 — Phase III Non-Inferiority Trial of Proton Versus Photon Therapy for Nasopharyngeal Carcinoma
· Phase 3
· recruiting
NCT06682442 — Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma
· NA
· recruiting
Other Jiangsu HengRui Medicine Co., Ltd. trials
Trials by the same sponsor.
NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults
· Phase 2
· completed
NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR
· Phase 1
· completed
NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。
· Phase 1
· completed
NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy
· Phase 1
· completed
NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd.
Last refreshed: 15 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03558191.